Cleared Traditional

K051440 - MAYFIELD INFINITY SKULL CLAMP

K051440 is the FDA 510(k) clearance for MAYFIELD INFINITY SKULL CLAMP by Integra Lifesciences Corp.. It is a Class 2 Neurology device (product code HBL) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K051440 · Integra Lifesciences Corp. · Neurology device
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Sep 2005
Decision
110d
Days
Class 2
Risk

K051440 is an FDA 510(k) clearance for the MAYFIELD INFINITY SKULL CLAMP. Classified as Holder, Head, Neurosurgical (skull Clamp) (product code HBL), Class II - Special Controls.

Submitted by Integra Lifesciences Corp. (Plainsboro, US). The FDA issued a Cleared decision on September 20, 2005 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4460 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra Lifesciences Corp. devices

Submission Details

510(k) Number K051440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date September 20, 2005
Days to Decision 110 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 148d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBL Holder, Head, Neurosurgical (skull Clamp)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4460
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBL Holder, Head, Neurosurgical (skull Clamp)

All 22
Devices cleared under the same product code (HBL) and FDA review panel - the closest regulatory comparables to K051440.
MAYFIELD DISPOSABLE AND REUSABLE TITANIUM SKULL PINS
K072208 · Integra LifeSciences Corporation · Sep 2007
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
K071458 · Integra LifeSciences Corporation · Jun 2007
MODIFICATION TO: MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020
K053045 · Integra LifeSciences Corporation · Nov 2005
CODMAN SKULL PINS (ADULT & CHILD), REUSABLE
K912005 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN DISPOSABLE SKULL PINS
K911723 · Codman & Shurtleff, Inc. · Sep 1991
CODMAN SKULL CLAMP
K913170 · Codman & Shurtleff, Inc. · Sep 1991